Application with 1. Meta-analyses; 2. One pivotal study - Scientific guideline
This document provides guidance on two topics: the use of meta-analysis and the use of only a single pivotal study in phase III clinical development.
Keywords: Meta-analysis, one pivotal trial, internal validity, external validity, selection bias, heterogeneity, extrapolation, assessment of consistency, multi-regional clinical trials, centre, interaction test, level of evidence for drug licensing